Evaluation of a Simple Clinical Test to Detect the Risk of Falling in Patients With BPCO and Research for Predictive Factors of Fall Risk.

COPD Diagnosed Clinical Trial

— Equil-BPCO  

Official title:

Evaluation of a Simple Clinical Test to Detect the Risk of Falling in Patients With Chronic Obstructive Pulmonary Disease and Research for Predictive Factors of Fall Risk.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03152344
• Other study ID #: CHU-332
• Secondary ID: 2016-A01188-43
• Status: Completed
• Start date: January 2, 2017
• Est. completion date: October 27, 2017

Study information

• Verified date: August 2019
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The risk of falling in increased in patients with Chronic Obstructive Pulmonary Disease. To date, a screening test (the Berg Balance scale, BBS) is used to evaluate this risk but it spends 20 to 30 minutes to complete.

The aim of our study is to evaluate the sensitivity of a more straightforward test (Timed Up and Go, TUG)) to assess the fall risk. The TUG is routinely used in elderly to screen for frailty.

Description:

We will recruit COPD patients in stable condition (free of exacerbation of the disease for a month), 40 without chronic respiratory failure and 40 with home oxygen therapy.

The patients will be proposed to perform the following tests and to fill in questionnaires:

• Questionnaires: Elderly Falls Screening Test to quantify the falls in the last year, Hospital Anxiety and Depression Scale, Activities-specific Balance Confidence scale.

Tests:

• Berg Balance Scale measuring balance in 14 different functional tasks (abnormal cut-off value <56)

• Timed Up and Go evaluating the time to rise from a chair, walk 3 meters, turn around, walk back to the chair and sit down (abnormal cut-off value >12 seconds).

• 6 minute walk test evaluating endurance to submaximal exercise.

• Isokinetic maximal force of the quadriceps at 60°/s

• Balance control: posturography consisting in measuring variations when standing on a force platform.

• Body composition assessment through Dual Xray Absorptiometry (DXA), to measure body muscle mass and more specifically appendicular muscle mass index as a criteria of sarcopenia, and bone mineral density.

• Blood analysis: a blood sample will be withdrawn to measure calcium, phosphorus, vitamin D, albumin transthyretin, cell count, C reactive protein.

Analysis of the results:

We will calculate the sensitivity of the TUG test (abnormal test) to detect fall risk as assessed by an abnormal BBS score.

Moreover, in fallers, we will search for predictive factors. More specifically, we will look for the role of a decreased quadriceps force, a reduced muscle mass, a poor tolerance of exercise, the presence of hypoxia (severity of the disease).

Perspectives:

When validated as a screening test for the risk of falling in COPD patients, the TUG test could be used routinely by physiotherapists as a more simple and faster test and will enable to prevent falls through initiation of a balance control training program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 27, 2017
• Est. primary completion date: October 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• COPD confirmed by pulmonary function tests

• Long term oxygen therapy since at least 3 months in the LOT+ subgroup

Exclusion Criteria:

• Exacerbation of COPD necessitating an hospitalization or an oral corticosteroid treatment, in the last 4 weeks

• Pulmonary rehabilitation in the last 3 months

• Any neurological disease affecting balance control.

• Inability to perform a walk test

Related Conditions & MeSH terms

• COPD Diagnosed

Intervention

Procedure:
• Timed Up and Go
It's a functional test evaluating the time to rise from a chair, walk 3 meters, turn around, walk back to the chair and sit down (abnormal cut-off value >12 seconds).

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand	Auvergne

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Centre de Recherche en Nutrition Humaine d'Auvergne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the Timed Up and Go test and the Berg Balance scale	Comparison of the consistency of abnormal value of the Timed Up and Go test and the Berg Balance scale	at day 1
Secondary	Sensitivity of the TUG test and the BBS	to detect fall as assessed by the Elderly Falls Screening Test.	at day 1
Secondary	Difference in BBS score	between COPD patients without and with chronic respiratory failure (LOT+/- subgroups).	at day 1
Secondary	Identify predictive factors of fall risk	walk distance, quadriceps force, muscle mass, balance control.	at day 1